Application 065418

Type: ANDA
Sponsor: ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFDINIR	CEFDINIR	CAPSULE;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065418-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB		2007-07-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A065418-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065418-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065418-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065418-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065418-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065418-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065418-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065418-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065418-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065418-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065418-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065418-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065418-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065418-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065418-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065418-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065418-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065418-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065418-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065418-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065418-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065418-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065418-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065418-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065418-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065418-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065418-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065418-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065418-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065418-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065418-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065418-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065418-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065418-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065418-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065418-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065418-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065418-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065418-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065418-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065418-001	AB	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	BluePoint Laboratories	e342b7cf-f527-476e-8119-b1fd81c58b55	2023-03-29	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Teva Pharmaceuticals USA, Inc.	a1f49fe1-b511-4f6b-a912-8ae8662d95a5	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Proficient Rx LP	be963e80-e298-49a0-a52f-3d4dcded7c8c	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Proficient Rx LP	8305b5d8-53b3-475a-b263-07d5fd81392a	2022-09-01	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
cefdinir	CEFDINIR	Ascend Laboratories, LLC	efb5a975-75ec-46e1-ba84-f68d0b9bf36f	2022-06-29	Warnings, Adverse reactions	Name fallback brand name: cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Proficient Rx LP	444cd2c4-836d-40d5-a307-d719fe83e763	2022-05-02	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Proficient Rx LP	f22acd90-5dc4-406d-af78-5f9c3a674647	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Sandoz Inc	38f6adf7-e26c-4764-8ec9-360813874dd4	2020-02-24	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Proficient Rx LP	f30d01e3-0839-4928-a45a-b46c89aa454c	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Teva Pharmaceuticals USA, Inc.	de3441e3-7fd2-4d29-a8b7-0f9b66e35c9c	2018-08-31	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42043-250	Cefdinir	Cefdinir	OrchidPharma Inc	ANDA	Current
43063-597	Cefdinir	Cefdinir	PD-Rx Pharmaceuticals, In	ANDA	Current
63187-593	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
67296-1291	Cefdinir	Cefdinir	RedPharm Drug, Inc.	ANDA	Current
67296-1291	Cefdinir	Cefdinir	RedPharm Drug, Inc.	ANDA	Current
68071-3032	Cefdinir	Cefdinir	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3032	Cefdinir	Cefdinir	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-9760	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9760	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current